Safety assessment of herbal food supplements: Ethanol and residual solvents associated risk

Abstract

Availability of herbal food supplements and belief in their efficacy and safety contributed to their increased use, causing exposure to ethanol and residues of extraction solvents. Liquid herbal food supplements (103) were purchased from pharmacies (Novi Sad, Serbia) during 2021, and analysed for presence of ethanol and selected residual solvents using HSS-GC-MS method. Ethanol was not quantified in only one of 18 products for infants or toddlers less than two years old. WHO proposed requirement for ethanol content in products intended for children less than 6 years old (<0.5%) was not met by 26 samples, in products for children 6–12 years (<5%) by four samples and in products for children over 12 years (<10%) by two samples. Calculated blood alcohol concentrations exceeded the relevant toxicological levels for 37 samples following a single dose, and for 31 samples in case of accidental poisoning (entire package). Methanol was quantified in 38 samples, in one of them above the limit of 0.05%, (Ph. Eur. 9), causing exceedance of permitted daily exposure. Other residual solvents were quantified rarely and in low concentrations. Study findings confirmed a need for raising awareness of professionals and public and establishment of strict guidelines for ethanol content and labelling.